case study

Portfolio Risk Management

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Portfolio Risk Management

Client

Middle-market private equity firm in need of risk management support

Target

Pre-revenue portfolio company

Industry

Pharmaceutical

Business Challenge

Conducting a new product development assessment for a portfolio company

Project Timeline

Pre-launch research & target product profile development – 6 months

Internal implementation of portfolio risk matrix – 3 months

Commercial pipeline analysis – Ongoing

 

Private Equity Challenge

A global private equity firm based in the United States approached RCA to conduct a new product development assessment for a portfolio company. The client eeded industry expertise based on preclinical commercial opportunities in the pipeline and category metrics from the internal product management team. The client also had a need for a voice-of-business research study to be conducted to understand employee attitudes about the key drivers set in place by the commercialization team. Finally, the middle-market PE firm needed data to set a longer-term acquisition strategy based on channel potential and potential acquisition targets that made the most sense for the portfolio.

 

RCA Approach

Qualitative information was used to create a multifactor risk assessment to determine each target product profile and the perception of risk. The assessment included the following key requirements:

  • Business strength factors were ranked by employees who compared key attributes across intended product profiles (e.g. product differentiation, brand equity, etc.)
  • Market attractiveness factors were ranked by employees who compared key attributes across intended product profiles (e.g. market size, competitive forces, etc.)

Voice-of-business research was then conducted to populate the risk assessment. Data was collected through employee responses based on the perspective of product profiles, business strength, and market attractiveness factors.

 

Private Equity Results

Perception mapping and matrix-style results were presented to the client team after all team members completed their voice-of-business survey. Results were weighted across all factors based on team inputs, the importance of strategic factors in relation to other factors, and employee expertise of their specific product category.

RCA discovered many unique data points for consideration by the portfolio company and private equity firm from the risk assessment:

  • The business strength of the preclinical product alternatives were ranked higher than previously anticipated.
  • Market growth rate was perceived to make a greater impact on future sales than current market size.
  • Competitive rivalry in the channel was the greatest risk management factor by the portfolio leadership team. This included a lack of awareness of disruption potential in the channel or the threat of new category competition.
  • Government regulatory environment was consistent across the model due to the compliance-based nature of the life sciences industry. However, power of existing channel partners showed in the data analysis as a differentiator when it came to who could influence the regulatory speed-to-market.

The client team developed talking points for the Board of Directors based on this analysis:

  • Opportunities that were previously considered a secondary priority (e.g. smaller profit margin potential in large sales channels) were to be reassessed based on the sales channel potential.
  • When the cost of capital to develop a preclinical product was held constant across the risk management model, technology and innovation costs quickly escalated.
  • One of the preclinical products achieved a higher score based on the strategic partner in place who could assist commercialization and market sales.
  • Macro-environment change and potential for channel disruption were determined to be decisive gaps for both the private equity firm and portfolio company.

 

Private Equity Takeaways

  • An internal risk management council was established by the Board of Directors to consider how unknown channel disruption may impact their portfolio risk or future new product introductions.
  • Business strength factors signaled the anticipation of success as a pre-approval product portfolio. This was important to the PE firm and portfolio company as a positive indicator even though commercialization lagged behind the existing entrants and competitors.
  • The market growth rate analysis helped the PE firm to recalibrate leadership guidance that pursuing slower CAGR markets larger in size remained just as important as faster growing channels.
  • Portfolio company leadership added additional product management headcount to address the lack of understanding of disruption potential and new category competition.
  • The emerging importance of technology and innovation from the assessment results led to a new project where the portfolio company began examining leveraging manufacturing automation and big data.
  • Recognizing the importance of channel partner strength led the PE firm to reconsider their portfolio bolt-on strategy with existing channel partnerships as a higher priority in targets being considered.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation 

Regulatory Compliance Associates has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.

In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Client

Middle-market private equity firm in need of risk management support

Target

Pre-revenue portfolio company

Industry

Pharmaceutical

Business Challenge

Conducting a new product development assessment for a portfolio company

Project Timeline

Pre-launch research & target product profile development – 6 months

Internal implementation of portfolio risk matrix – 3 months

Commercial pipeline analysis – Ongoing

 

Private Equity Challenge

A global private equity firm based in the United States approached RCA to conduct a new product development assessment for a portfolio company. The client eeded industry expertise based on preclinical commercial opportunities in the pipeline and category metrics from the internal product management team. The client also had a need for a voice-of-business research study to be conducted to understand employee attitudes about the key drivers set in place by the commercialization team. Finally, the middle-market PE firm needed data to set a longer-term acquisition strategy based on channel potential and potential acquisition targets that made the most sense for the portfolio.

 

RCA Approach

Qualitative information was used to create a multifactor risk assessment to determine each target product profile and the perception of risk. The assessment included the following key requirements:

  • Business strength factors were ranked by employees who compared key attributes across intended product profiles (e.g. product differentiation, brand equity, etc.)
  • Market attractiveness factors were ranked by employees who compared key attributes across intended product profiles (e.g. market size, competitive forces, etc.)

Voice-of-business research was then conducted to populate the risk assessment. Data was collected through employee responses based on the perspective of product profiles, business strength, and market attractiveness factors.

 

Private Equity Results

Perception mapping and matrix-style results were presented to the client team after all team members completed their voice-of-business survey. Results were weighted across all factors based on team inputs, the importance of strategic factors in relation to other factors, and employee expertise of their specific product category.

RCA discovered many unique data points for consideration by the portfolio company and private equity firm from the risk assessment:

  • The business strength of the preclinical product alternatives were ranked higher than previously anticipated.
  • Market growth rate was perceived to make a greater impact on future sales than current market size.
  • Competitive rivalry in the channel was the greatest risk management factor by the portfolio leadership team. This included a lack of awareness of disruption potential in the channel or the threat of new category competition.
  • Government regulatory environment was consistent across the model due to the compliance-based nature of the life sciences industry. However, power of existing channel partners showed in the data analysis as a differentiator when it came to who could influence the regulatory speed-to-market.

The client team developed talking points for the Board of Directors based on this analysis:

  • Opportunities that were previously considered a secondary priority (e.g. smaller profit margin potential in large sales channels) were to be reassessed based on the sales channel potential.
  • When the cost of capital to develop a preclinical product was held constant across the risk management model, technology and innovation costs quickly escalated.
  • One of the preclinical products achieved a higher score based on the strategic partner in place who could assist commercialization and market sales.
  • Macro-environment change and potential for channel disruption were determined to be decisive gaps for both the private equity firm and portfolio company.

 

Private Equity Takeaways

  • An internal risk management council was established by the Board of Directors to consider how unknown channel disruption may impact their portfolio risk or future new product introductions.
  • Business strength factors signaled the anticipation of success as a pre-approval product portfolio. This was important to the PE firm and portfolio company as a positive indicator even though commercialization lagged behind the existing entrants and competitors.
  • The market growth rate analysis helped the PE firm to recalibrate leadership guidance that pursuing slower CAGR markets larger in size remained just as important as faster growing channels.
  • Portfolio company leadership added additional product management headcount to address the lack of understanding of disruption potential and new category competition.
  • The emerging importance of technology and innovation from the assessment results led to a new project where the portfolio company began examining leveraging manufacturing automation and big data.
  • Recognizing the importance of channel partner strength led the PE firm to reconsider their portfolio bolt-on strategy with existing channel partnerships as a higher priority in targets being considered.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation 

Regulatory Compliance Associates has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.

In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

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